A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Safety measured by adverse events
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
详细描述
The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An informed consent document signed and dated by the subject.
- •Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
排除标准
- •Clinically relevant evidence or history of illness or disease.
- •Pregnant or nursing females.
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- •A positive urine drug screen at screening or Day -
- •Current tobacco smokers or use of tobacco within 1 months prior to screening.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- •History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
- •Participation in a clinical trial within 30 days prior to the first dose of study drug.
研究组 & 干预措施
EDP-297 SAD Cohorts
EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration
干预措施: EDP-297 (Drug)
EDP-297 MAD Cohorts
EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days
干预措施: EDP-297 (Drug)
EDP-297 SAD Placebo Cohort
Matching placebo, oral solution, once daily in one single administration
干预措施: Placebo (Drug)
EDP-297 MAD Placebo Cohort
Matching placebo, oral solution, once daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety measured by adverse events
时间窗: Up to 21 Days in MAD Cohorts
次要结局
- Cmax of EDP-297(Up to 18 Days in MAD Cohorts)
- AUC of EDP-297(Up to 18 Days in MAD Cohorts)